Genome Engineering

Grand Scale Genome Engineering of Viruses, Bacteria, and Eukaryotes


Q1. The product which I want to bring to market to make a difference is as follows:
  1. My product is a 20-minute serological test which tests the presence of IgM and IgG antibodies to SARS-CoV-2, which will be present in blood up to 10-11 days from infection.
  2. It is based on a lateral-flow immunoassay which initially can be undertaken only in a lab, but has potential for home use.
  3. The test uses a fingerpick of blood and a small strip of special conjugate pad – the whole test equipment is contained in a single use plastic covering.
  4. The sample of blood is placed in a well and migrates with capillary action along a conjugate pad containing colloidal gold nano-particles which have SARS-CoV-2 recombinant antigens.
  5. If the sample contains the antibodies then it attaches to the gold nano-particles and forms a distinctive visual pattern which can be read on a scale.

Q2. The approval process of my device under the current pandemic scenario is as follows:
  1. On February 4, a public health emergency was announced which justifies the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of Covid-19, known as Emergency Use Authorizations (EUAs).
  2. Procedure was outlined on FDA Policy for Diagnostic Tests for Coronavirus Disease-2019 on March 16.
  3. The CDRH Website listing EUAs already has lateral-flow immunoassay tests for Covid-19 so my product should be a comparative device.
  4. There is a 15-page Word Document form “Test Kit Manufacturer: EUA Template” which can be completed
  5. The FDA is interested in early interactions with test developers and will review data on a rolling basis – encourages to reach out early before paperwork
  6. No mention of time to approve or costs

Q3. The non-urgent approval process for a med device in the United States is summarized as:
  1. An approval for a lateral-flow immunoassay test would be classified by the US FDA Center for Devices and Radiological Health (CDRH).
  2. There are comparative devices and so importantly there would be an existing product code – a much easier process than an entirely new device which can take 2 to 3 years of clinical trials and costs between $10 million and $20 million.
  3. A Lateral-flow immunoassay would also be a Class II or “moderate risk” and so PMN (501k) clearance, - a fast-track process for devices with substantive equivalence to existing device.
  4. PMN must be submitted to the FDA at least 90 days prior to anticipated marketing along with a fee of ($5,228) – at which point the FDA may determine predicate does not qualify or otherwise provide a confirmation that a review process has begun.
  5. In the first 15 days an acceptance reviewer will confirm passing to a lead reviewer who may likely need questions answering but will provide an acceptance within a further 45 days.
  6. Once FDA approval is given, the sponsor must register the business that will produce and distribute the device within the United States and “list” their device.
Reference
  1. JACC: Basic to Translational Science, Drugs, Devices, and the FDA: Part 2: An Overview of Approval Processes: FDA Approval of Medical Devices,2016 Van Norman, G